Recent scientific studies have
shown that the blood thinner, Pradaxa, may cause serious health
problems including internal bleeding and hemorrhaging in certain
populations of patients. These health issues may cause
death in some populations of patients. Further, there are
allegations that the drug manufacturer may have been aware of
certain dangers of the drug's use, but did not warn the public
in a timely manner of these health dangers.

New Studies and Research May Prompt
Pradaxa Internal Bleeding Lawsuits, Pradaxa Hemorrhaging Death
Lawsuits, Pradaxa Internal Bleeding Death Lawsuits, and other
Serious Injury or Fatal Pradaxa Lawsuits

In September 2011, Pradaxa became the subject
of an investigation in New Zealand after as many as five elderly
Pradaxa patients reportedly died as a result of internal
bleeding / hemorrhaging. Another 36 patients reportedly suffered
bouts of serious internal bleeding / hemorrhaging. New Zealand
media outlets reported that some families claimed the chain of
events leading to their relatives' deaths began when they
switched from warfarin to Pradaxa, and infections set in after
their conditions had deteriorated to the point of hospital
admission.

The New Zealand reports came weeks after
regulators in Japan asked the maker of Pradaxa to notify doctors
about potentially deadly bleeding / hemorrhaging in some Pradaxa
patients. According to a letter sent to Boehringer Ingelheim by
the country's health ministry, between March 14 and August11, 81
elderly patients taking Pradaxa suffered heavy bleeding /
hemorrhaging, leading to five deaths. Japanese officials
suggested that patients older than 70 may need a lower dose of
Pradaxa. Bleeding / hemorrhaging is also a side effect of older
blood thinners, such a warfarin. But warfarin bleeding can be
treated with vitamin K. There is no antidote available for
bleeding caused by Pradaxa and similar drugs, known as direct
thrombin inhibitors.

The U.S. Food and Drug Administration (FDA)
is evaluating post-marketing reports of serious bleeding events
in patients taking Pradaxa (dabigatran etexilate mesylate).
Pradaxa is a blood thinning (anticoagulant) medication used to
reduce the risk of stroke in patients with non-valvular atrial
fibrillation (AF), the most common type of heart rhythm
abnormality.

Facts about Pradaxa (dabigatran
etexilate mesylate)

Pradaxa (dabigatran etexilate) is a blood
thinner that was approved by the U.S. Food & Drug Administration
(FDA) in October 2010 to prevent blood clots in patients with
atrial fibrillation.

A blood thinner (anticoagulant) known as a
direct thrombin inhibitor. Approved to reduce the risk of stroke
and blood clots (systemic embolism) in patients with non-valvular
atrial fibrillation. Available as 75 mg and 150 mg oral
capsules. From approval in October 2010 through August 2011, a
total of approximately 1.1 million Pradaxa prescriptions were
dispensed and approximately 371,000 patients received Pradaxa
prescriptions from U.S. outpatient retail pharmacies.1

At this time, FDA continues to believe that
Pradaxa provides an important health benefit when used as
directed and recommends that healthcare professionals who
prescribe Pradaxa follow the recommendations in the approved
drug label (See Additional Information for Healthcare
Professionals).

Patients with AF should not stop taking
Pradaxa without talking to their healthcare professional.
Stopping use of blood thinning medications can increase their
risk of stroke. Strokes can lead to permanent disability and
death.

Bleeding that may lead to serious or even
fatal outcomes is a well-recognized complication of all
anticoagulant therapies. The Pradaxa drug label contains a
warning about significant and sometimes fatal bleeds. In a large
clinical trial (18,000 patients) comparing Pradaxa and warfarin,
major bleeding events occurred at similar rates with the two
drugs.

FDA is working to determine whether the
reports of bleeding in patients taking Pradaxa are occurring
more commonly than would be expected, based on observations in
the large clinical trial that supported the approval of Pradaxa.
(See Data Summary). FDA is working closely with the manufacturer
of Pradaxa (Boehringer Ingelheim) to evaluate the post-market
reports of bleeding.

FDA will communicate any new information on
the risk of bleeding and Pradaxa when it becomes available.

Additional Information for Patients

Pradaxa is an anticoagulant medicine that
reduces the risk of blood clots forming in your body and causing
a stroke. Having a stroke can cause permanent disability and
death. Do not stop taking Pradaxa without talking to your
healthcare professional. Stopping use of your blood thinner
suddenly can put you at risk of a stroke. Be aware that while
taking Pradaxa you may bruise more easily and it may take longer
for any bleeding to stop.

Call your healthcare professional and seek
immediate care if you develop any signs or symptoms of bleeding
such a

unusual bleeding from the gums

nose bleeding that happens often

menstrual or vaginal bleeding that is heavier
than normal

bleeding that is severe or you cannot control

pink or brown urine

red or black stools (looks like tar)

bruises that happen without a known cause or
that get larger

coughing up blood or blood clots

vomiting blood or vomit that looks like
coffee grounds.

Other symptoms of Pradaxa internal bleeding
may include:

Tiredness and Lethargy, Joint pain or
swelling

Headaches Dizziness Weakness

swelling of the arms, hands, feet, ankles or
lower legs

Death

Discuss any questions or concerns about
Pradaxa with your healthcare professional.

Report any side effects you experience to
your healthcare professional and the FDA MedWatch program using
the information in the “Contact Us” box at the bottom of the
page.

Additional Information for Healthcare
Professionals

If you prescribe Pradaxa, carefully follow
the approved indication and other recommendations, such as
dosage and administration, in the professional drug label. Make
sure your patients know the signs and symptoms of bleeding and
when to seek care. Pradaxa is eliminated by the kidneys,
therefore: Renal function should be assessed prior to treatment
with Pradaxa to determine the appropriate dose. Renal function
should be reassessed during treatment with Pradaxa if clinically
indicated (fluctuating renal function, diuretic use, hypovolemia),
and the dose should be adjusted following recommendations in the
label.

There is no need for dosage adjustment in
patients with mild to moderate renal impairment (creatinine
clearance [CrCl] > 30 mL/min). These patients should be given a
dose of Pradaxa 150 mg orally twice daily. For patients with
severe renal impairment, follow the recommended doses: For
patients with CrCl 15-30 mL/min, the recommended dose is 75 mg
orally twice daily. Dosing recommendations for patients with a
CrCl <15 mL/min or on dialysis cannot be provided.

Report adverse events involving Pradaxa to
the FDA MedWatch program, using the information in the “Contact
Us” box at the bottom of the page.

Data Summary Bleeding that may lead to
serious or even fatal outcomes is a well-recognized complication
of all anticoagulant therapies. In a large clinical trial
(18,000 patients) comparing Pradaxa (dabigatran etexilate
mesylate) and warfarin, major bleeding events occurred at
similar rates with the two drugs. At present, the FDA is
evaluating the post-marketing reports of serious bleeding in
patients taking Pradaxa submitted to the Adverse Events
Reporting System (AERS) database. While serious, even fatal
events have been reported, the FDA is analyzing the events to
determine whether the reports of bleeding in patients taking
Pradaxa are occurring more commonly than would be expected,
based on observations in the large clinical trial that supported
the approval of Pradaxa.

Complicating this analysis, many factors can
influence whether or not adverse effects are reported,
particularly the length of time a drug has been marketed,
whether or not the adverse effect is described in the drug
label, and the amount of publicity about an event or safety
concern.

For patients with non-valvular AF, the main
alternative to Pradaxa is warfarin. Because warfarin has been
marketed for over 50 years and is well-known to cause bleeding,
patients and healthcare professionals are not likely to report
bleeding in association with warfarin. Thus, a simple comparison
between Pradaxa and warfarin with respect to the numbers of
post-marketing reports of bleeding is of limited value.

FDA is working with the manufacturer,
Boehringer Ingelheim, to analyze the post-market reports for
evidence of inappropriate dosing, use of interacting drugs, or
other clinical factors that might lead to a bleeding event.

FDA is also using its Mini-Sentinel active
surveillance system to compare new users of Pradaxa and warfarin
with respect to the likelihood of being hospitalized for
bleeding.

At this time, FDA believes the benefits of
Pradaxa continue to exceed the potential risks when the drug is
used appropriately following the approved drug label. FDA
recommends that healthcare professionals continue to prescribe
Pradaxa following the recommendations in the drug label.

Texas Dangerous Drug Attorney Jason Coomer
commonly works with other lawyers throughout Texas and the
United States including Houston Pradaxa Lawyers, San Antonio
Pradaxa Lawyers, Dallas Pradaxa Lawyers, Chicago Pradaxa
Lawyers, Illinois Pradaxa Lawyers, and other Dangerous Drug
Claim Lawyers. By sharing information and working together, his
law firm and other firms throughout Texas are able to provide
better representation for there clients.

It is well established that
many large corporations have profited from selling toxic products or
products that cause toxic exposure without regard to the health
consequences of the products. Some of the most well known toxic
products are asbestos products and bad drugs. The asbestos products
have been found to cause mesothelioma and several forms of cancer
and other asbestos diseases, while dangerous drugs have been linked
to death, serious heart problems, drug interactions, and suicide.
Other dangerous products that have been linked to serious disease
include silica, chemical pollutants, lead, radon, EMFs,
welding rods,
toxic mold infestations
and other environmental toxins have caused death and serious harm to
millions. In the work environment alone undisclosed and known
toxins including asbestos, silica, and welding rods have caused
occupational diseases and fatalities including mesothelioma,
numerous forms of cancer, and Parkinson's disease.

This web site was created by Texas Toxic Tort Lawyer Jason
Coomer and is intended only as general information on some of the
most dangerous products and toxic products that have been sold by
drug manufacturers, medical device manufacturers, and asbestos
manufacturers, or are in use by large companies attempting to profit
and make money from the sale of dangerous products that can cause
serious toxic exposures. For more information on a dangerous
product or toxic exposure follow the links found above,
e-mail an inquiry to
info@toxicdoselaw.com,
or submit an inquiry.

This website provides basic
information on some well established toxins and some potential
toxins that are best to avoid. Overall, ToxicDoseLaw.com and
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minimizing exposure to potential toxins until they can be proven
nontoxic.

For more information on the ToxicDoseLaw.com or
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